Assisting PI to administer the clinical trials in accordance with the SOP, ensuring the clinical trials are conducted in accordance with GCP guidelines and quality.

Major Responsibilities

Describe the tasks, duties, and responsibilities the employee who is working on this role is supposed to carry out. List the responsibilities in the order of their importance.

• Follow the assignment and direction by director of department.
• Site Start-up:
  • Documents Submission and Kick off meeting.
  • Site start-up.
• Project Execution and Management:
  • ICF Management.
  • Assist in the screening, enrollment, and follow-up visit of subjects.
  • Subject noncompliance behavior management.
  • Data collection and source data management.
  • Trail drug management.
  • To monitor with CRA, QA, and QC.
• Data entry and management:
  • Data collection and source document management.
  • Data Entry.
• Assist AE, SAE, PD record and report.
• Site Close-out.
• Administering the clinical trial properly and assisting to solve problems.
• Support other colleagues to implement ongoing projects or affairs. Participate voluntarily in all kinds of works and various activities of department.
• Participate in audit by customer and regulatory agencies.
• Assist in project quality, schedule, resource allocation and management.
• Perform the tasks assigned by line manager.
• Organizing, stamping, distributing, sending, and retaining documents, etc (Administrator).
• Clinical Research Coordinator Trainee:
  • Complete various types of coaching and training assigned by the company.
  • Complete the GCP internal exam.
  • Participation in project practice activities under compliance.

Qualifications & Experience

Education

• College above, graduated in Medicine, Nursing, and Pharmacology related departments graduation.

Knowledge, Skills, and Abilities

• Provided with knowledge of GCP.
• Good command of English.
• Familiar with office and Project software.

Experiences

• Senior Clinical Research Coordinator:
• 2 years and above working experience as CRC or in clinical research industry is preferred.
• Clinical Research Coordinator II:
• 1 year and above working experience as CRC or in clinical research industry is preferred.
• Clinical Research Coordinator I:
• Half a year and above working experience as CRC or in clinical research industry is preferred.